It's every parents nightmare. Your infant is terrifyingly ill and you don't know what to do or even why--what is happening. The life of your infant is in your hands but they cant tell you what is wrong and where it hurts.
Earlier this month, such a nightmare occurred in 15 states. At least, 31 infants became sick and were hospitalized with botulism from consuming ByHeart brand infant formula.
Botulism, a gram-positive bacterium found in soil, can cause paralysis, respiratory failure and death. A medical emergency, it is prevented in the manufacturing process by high-heat sterilization, moisture and acidity control and refrigeration.
ByHeart, a nine-year-old infant nutrition company that gained popularity during the 2022 infant formula shortage is the target of a lawsuit filed by a Kentucky couple, alleging negligence and failure to warn about dangerous pathogens despite a history of similar manufacturing infractions.
ByHeart recalled the formula this month amid urgent government warnings.
According to its marketing, the companys patented protein blend in its infant formula gets closest to breast milk thanks to alpha-lac (which is at actual breast milk levels), lactoferrin, a protein found in colostrum and partially hydrolyzed proteins.
With plants in Pennsylvania, Iowa; and Oregon, ByHeart has claimed obsessive and rigorous safety and quality standards but this months health scare is, shockingly, not its first.
In 2023, the company shut down its Pennsylvania facility because of contamination from a different microbe--the tenacious gram-negative bacterium, Cronobacter sakazakii. The FDA documented a leaking roof and 2,500 dead insects in the production area as well as failure to maintain microbe-killing temperatures at the plant.
Interview With Baby Food Expert
We recently spoke with Monique Alarcon, attorney at Wisner Baum LLP, about the current recall.
MR: ByHeart gained footing during the 2022 US infant formula shortage. Can you remind readers what caused the shortage?
MA: Theres big litigation about this. Enfamil and Similac put out a premature infant formula that was specifically for preemie babies in the ICU and that unfortunately ended up causing this condition called necrotizing enterocolitis or NEC. So that actually led to a formula shortage because they were such a popular and big part of the market.
MR: You have been involved in other infant food dangers besides the botulism scare.
MA: We represent thousands of families [whose babies] have suffered neurodevelopmentalinjury because of heavy metals in baby food. We have seen an industry-wide problem wherethey are putting out food for the most vulnerable population babies, and that food, baby food, is contaminated, with heavy metal. So weve seen this playbook before where they [themanufacturers] claim it's the best food for the baby, the most nutritional and lo and behold, it's ending these babies to the hospital with really severe symptoms. So that's the reason we've gotten involved. And I think that, you know, we have a history of doing this work.
MR: Even though, as you say, the California Department of Public Health tested and found the ByHeart botulism in products, there may be some obfuscation going on...
MA: So, some of these [exposed] families bought from a store, a retailer. Other families bought directly from ByHeart in their subscription program because the [company is] also a direct to consumer company. But [now the company says] well, that can that was tested, was an opened can, so we don't know They're literally trying to blame the store.
MR: What are the immediate legal implications?
MA: Theres already been a number of individual, kind of personal injury cases filed. Theres also been a couple of different class actions that have been filed about economic damages. Theres the fallout of not only did I purchase this product and Im out of pocket for that, cash-- maybe theyre getting a refund, maybe not in full-- but people have several formula associated products that now they dont know what to do with. Well, I wouldn't feel safe using [the bottles] right now.
MR: What about treatment costs? BabyBIG is an FDA-approved medication for infant botulism but it cost $69,300 per patient in California in 2025.
MA: BabyBig, [is] essentially an antitoxin that they immediately give the babiesas soon as possible. I think that the sooner they receive it, the better outcome they have but its not available everywhere. There was one case, I think the family was in Arizona, in which they had to fly in the medication from California. Maybe we are preventing what many years ago would have been fatal but long-term neurodevelopmental consequences can result. Babies have an immature digestive system, so they cant process botulism spores the way that we can. The recommendation is that they not have honey, for example, because it can contain the [botulism] spores.
MR: How can something like this be prevented?
MA: From a legal perspective, when a company like this puts a product onto the market that is dangerous, theyre liable--theres strict liability. [But] the FDA is not as involved as the general public thinks that they are and it is incumbent upon the manufacturers to ensure that their product is safe from start to finish--because the FDA is not there at every step of the way. Sure, they may have certain regulations that govern that industry but it is incumbent upon the manufacturers to ensure that their product is safe from start to finish. END
(Article changed on Nov 21, 2025 at 1:04 PM EST)
(Article changed on Nov 21, 2025 at 1:09 PM EST)
13
